This is an exploratory mixed-methods research study that compares an efficacious behavioral HIV-prevention intervention (3MV) alone to the behavioral HIV-prevention intervention combined with a biomedical intervention (PrEP). After completing the 3MV behavioral intervention, participants will be randomly assigned to one of three study arms: 1) daily FTC/TDF as PrEP, 2) placebo pill control, or 3) "no pill" control. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks. Youth who decline to participate will be asked to complete a brief survey about their opinions on PrEP. Qualitative interviews will be completed with six study participants and the study coordinators at the end of the trial to explore further the issues of trial acceptability and feasibility. Finally, focus groups will be conducted to explore feasibility and acceptability issues with YMSM who meet all eligibility requirements of the study except for not being age 18 or older, but are at least 16 years of age.

Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:

To evaluate the specific components of a PrEP delivery protocol that would be necessary to include in a future trial that will examine the effectiveness of PrEP as a prevention approach for YMSM at high risk for HIV infection. [ Time Frame: 28 weeks ] [ Designated as safety issue: Yes ]

Concurrent participation in an HIV vaccine study or other investigational drug study; or

Known allergy/sensitivity to the study drug or its components.

Use of disallowed medications

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01033942